Skip to main content
Evidence-Based Supplement Research
Evidence-Based Supplement Research
Pillser
Search
Sign UpLog In

Vitamin K insufficiency and the prophylaxis strategy in term healthy infants: A multicentre study.

  • 2023-12-09
  • European journal of clinical investigation 54(4)
    • Serafina Perrone
    • Giuseppe De Bernardo
    • Chiara Lembo
    • Valentina Dell'Orto
    • Maurizio Giordano
    • Virginia Beretta
    • Chiara Petrolini
    • Lucia Gambini
    • Anna Laura Toni
    • Gianni Parigi
    • Ilenia Fontanarosa
    • Maria Pia Natale
    • Gabriele D'Amato
    • Desiree Sordino
    • Giuseppe Buonocore

Study Design

Type
Observational
Population
105 newborns who were exclusively breastfed
Methods
Prospective observational study, PIVKA-II levels measured using a sandwich-type enzyme-linked immunosorbent assay
Duration
3 months
Funding
Unclear

Background/aim

Late vitamin K deficiency bleeding (VKDB) during early infancy is a serious problem worldwide. Vitamin K (VK) deficiency commonly occurs in newborns who are exclusively breastfed. Protein Induced by VK Absence (PIVKA-II) has been identified as an early indicator of subclinical VK deficiency in neonates, surpassing prothrombin time. To assess PIVKA-II levels at 48 h, 1 and 3 months of age in full-term newborns who were exclusively breastfed and received varying VKDB prophylaxis regimens.

Methods

A prospective observational study was conducted in four hospitals, enrolling 105 newborns. PIVKA-II levels were measured using a sandwich-type enzyme-linked immunosorbent assay.

Results

At 48 h of age, there was no significant difference in PIVKA-II concentrations between newborns who received intramuscular administration of 1 mg of phylloquinone (VK1) and those who received oral administration of 2 mg of VK1 at birth. At 1 and 3 months of life, infants who received any supplementation regimen between 2 and 14 weeks exhibited significantly lower PIVKA-II concentrations compared to infants who received only 1 mg of intramuscular VK1 at birth. The prophylaxis involving a dose of 1 mg of intramuscular VK1 at birth followed by oral administration of 150 μg/day of VK1 from the 2nd to the 14th week of life showed the lowest PIVKA-II blood concentrations.

Conclusions

Oral supplementation of VK1 after discharge significantly reduced PIVKA-II concentrations in exclusively breastfed term infants. These findings suggest the importance of oral VK1 supplementation in exclusively breastfed infants during their first 3 months of life to avoid the risk of VK insufficiency.

Research Insights

  • Vitamin K1→Reduced PIVKA-II Concentration

    The prophylaxis involving a dose of 1 mg of intramuscular VK1 at birth followed by oral administration of 150 μg/day of VK1 from the 2nd to the 14th week of life showed the lowest PIVKA-II blood concentrations.

    Effect
    Beneficial
    Effect size
    Large
    Dose
    1 mg intramuscular at birth followed by oral 150 μg/day from 2nd to 14th week
Back to top